MAUDE Adverse Event Report: AESCULAP AG & CO KG YASARGIL TI PERM STD-CLIPSLT-CVD 6.5MM; CEREBRO VASCULAR CLIPS

Model Number FT742T

Device Problem Material Deformation (2976)

Patient Problem No Information (3190)

Event Date 03/07/2014

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).The surgeon clipped the operative site by ft714t and ft742t in tandem.The surgeon found a clip had slipped off when the angiography image was reviewed.Which clip (ft714t or ft742t) was slipped off is under investigation.) state of brain aneurysm: dome diameter - 4mm; neck diameter - 2mm.

Manufacturer Narrative

Us reporting agent notified on (b)(4) 2014.Mfg site eval: clips received show traces of wear which may be a sign of multiple use, or improper use of application forceps.There are no indications of mfg or material defects.The cause of the failure can not be determined.

• Brand Name: YASARGIL TI PERM STD-CLIPSLT-CVD 6.5MM
• Type of Device: CEREBRO VASCULAR CLIPS
• Manufacturer (Section D): AESCULAP AG & CO KG; tuttlingen DE 78532
• Manufacturer (Section G): AESCULAP AG & CO KG; po box 40; tuttlingen 7850 1; GM 78501
• Manufacturer Contact: michelle link ; 615 lambert pointe dr; hazelwood, MO 63042 ; 3145515938
• MDR Report Key: 3805229
• MDR Text Key: 4367220
• Report Number: 2916714-2014-00245
• Device Sequence Number: 1
• Product Code: HCH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K970050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FT742T
• Device Catalogue Number: FT742T
• Device Lot Number: 51894500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other